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InspireMD Piper Sandler 37th Annual Healthcare Conference summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Piper Sandler 37th Annual Healthcare Conference summary3 Dec, 2025
Key clinical data and market trends
CREST-2 trial showed statistically significant benefit for stenting over medical management, accelerating the shift from open surgery to endovascular approaches for carotid disease.
CMS approval of the NCD in October 2023 expanded the market for stenting, supporting a stenting-first approach.
Feedback from both interventionalists and vascular surgeons is highly favorable, with expectations for more patients to be treated earlier in their disease.
Closed-cell and second-generation stents, such as CGuard, demonstrated superior outcomes in meta-analyses and contributed positively to CREST-2 results.
The shift is expected to increase the number of patients treated and the proportion receiving stents, not just the number of operators.
Commercial launch and financial outlook
U.S. commercial launch began in Q3 2024 with a trained sales force, doubling to about 30 reps, and over 100 patients treated early in the launch.
The company is focused on a controlled rollout, prioritizing quality of experience and physician adoption.
Q3 2024 revenue was $2.5 million ($2M international, $0.5M U.S.), with Q4 guidance of $2.5–3M and expectations to reach the higher end.
Growth is driven by increased U.S. adoption and continued international performance.
No specific number of accounts disclosed, but commercial trends remain positive.
Pipeline and clinical development
C-GUARDIANS II trial (CGuard with EnRoute neuroprotection) is progressing well, targeting FDA submission in H1 2026.
C-GUARDIANS III (SwitchGuard neuroprotection system) to start after Q1 2026, with FDA clearance targeted for H1 2027; trial will enroll ~105 patients at 25 sites.
SwitchGuard system aims to maintain familiar functionality for vascular surgeons, with added features for safety and ease of use; pricing strategy aims for a premium but within market norms.
Early feasibility study for tandem lesions is over 50% enrolled, targeting neurointerventionalists and acute stroke settings.
Success in acute stroke settings is measured differently, and future direction will depend on clinical outcomes and neuro community adoption.
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Frequently asked questions
InspireMD Inc. is a medical device company specializing in the development and commercialization of its proprietary MicroNet stent platform technology. This technology is primarily aimed at addressing complex vascular and coronary diseases. The company's key products include the CGuard carotid Embolic Prevention System (CGuard EPS) and the MGuard prime embolic protection system, which are designed for carotid artery applications and coronary interventions, respectively. InspireMD's strategy involves selling its medical devices through local distribution partners, extending its reach across multiple regions. The company was established in 2005 and is headquartered in Tel Aviv-Yafo, Israel. Its shares are listed on the NASDAQ.
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